DigiLine

GUDID D769DGLIAL0

DigiLine Aligner

PARK DENTAL RESEARCH CORP

Orthodontic progressive aligner
Primary Device IDD769DGLIAL0
NIH Device Record Keyd42a6b4c-77f8-4785-9572-a3a3d69aa371
Commercial Distribution StatusIn Commercial Distribution
Brand NameDigiLine
Version Model NumberDGL-IAL
Company DUNS011441508
Company NamePARK DENTAL RESEARCH CORP
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-243-7372
Emailinfo@pdrus.com
Phone1-800-243-7372
Emailinfo@pdrus.com
Phone1-800-243-7372
Emailinfo@pdrus.com
Phone1-800-243-7372
Emailinfo@pdrus.com
Phone1-800-243-7372
Emailinfo@pdrus.com
Phone1-800-243-7372
Emailinfo@pdrus.com
Phone1-800-243-7372
Emailinfo@pdrus.com
Phone1-800-243-7372
Emailinfo@pdrus.com
Phone1-800-243-7372
Emailinfo@pdrus.com
Phone1-800-243-7372
Emailinfo@pdrus.com
Phone1-800-243-7372
Emailinfo@pdrus.com
Phone1-800-243-7372
Emailinfo@pdrus.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD769DGLIAL0 [Primary]

FDA Product Code

NXCAligner, Sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-07
Device Publish Date2024-07-30

Devices Manufactured by PARK DENTAL RESEARCH CORP

D76918040 - IMTEC 2024-11-13 Basic Brower SGS
D7690450100 - IMTEC 2024-09-04 Combo Pack
D769IMXP50100 - IMTEC 2024-09-04 XP StarVent Implant w/ Cover Screw
D769IM2511CO0 - IMTEC 2024-08-29 Lew MDI Implant Collared
D769IM2513CO0 - IMTEC 2024-08-29 Lew MDI Implant Collared
D769IM2513XO0 - IMTEC 2024-08-29 Lew MDI Implant Non-Collared
D769IM2515XO0 - IMTEC 2024-08-29 Lew MDI Implant Non-Collared
D769IM2517CO0 - IMTEC 2024-08-29 Lew MDI Implant Collared

Trademark Results [DigiLine]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIGILINE
DIGILINE
97501031 not registered Live/Pending
PDR/Orchestrate LLC
2022-07-13
DIGILINE
DIGILINE
79073679 not registered Dead/Abandoned
Velpa Enveloppen B.V.
2009-08-06
DIGILINE
DIGILINE
78168205 2907196 Dead/Cancelled
Digi International Inc.
2002-09-26
DIGILINE
DIGILINE
78013025 not registered Dead/Abandoned
Kirchoff, Timothy Paul
2000-06-16
DIGILINE
DIGILINE
77800840 not registered Dead/Abandoned
SPICERS
2009-08-10
DIGILINE
DIGILINE
75710687 2931025 Live/Registered
Pfeiffer Vacuum GmbH
1999-05-20
DIGILINE
DIGILINE
75083316 2043479 Dead/Cancelled
Southwestern Bell Telephone Company
1996-04-03
DIGILINE
DIGILINE
74499614 not registered Dead/Abandoned
ACC Corp.
1994-03-14
DIGILINE
DIGILINE
72392585 0925506 Dead/Expired
ITEK CORPORATION
1971-05-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.